Extractables & Leachables

Extractables and leachables are materials that migrate from packaging system components, such as container and closure systems, and may contaminate the drug product. A comprehensive approach is required to analyze for the variety of possible extractable and leachable materials.

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What are Extractables?

Extractables are compounds that migrate from the contact surface under more aggressive conditions such as elevated temperature, extended contact time, or aggressive solvent system. Any component that is added to or pulled from the device or the materials used to make the device, including degradants and residuals.

What are Leachables?

Leachables are compounds that migrate from the contact surface under normal conditions of exposure. Released materials may include plastic components, elastomers, coatings, accelerants, and anti-oxidants. Degradation products from gamma and e-beam sterilization and residual solvents may also be present.

Extractable and Leachable Study Design

Extractables and leachables studies are designed to be optimized and customized for the pharmaceutical container or closure under investigation, such as materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, type of medicinal product, route of administration, dosing regimen, and associated threshold requirements.

Exhaustive extractions using solvents with a range of polarity (polar, non-polar, mid-range) may be conducted to identify extractable materials These extractable materials will be referenced against known target compounds from material and container preparation and processing. Leachable materials may be extracted using model solvent system comparable to end use applications.

Toxikon’s Expertise in Extractables & Leachables Testing

Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in medical devices and pharmaceutical products. The demand for these types of studies by U.S. and other governing bodies is increasing, as data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing, and other materials, potentially rendering drug products unsafe. These materials include, but are not limited to polymers and other plastics, elastomers, coatings, accelerants, and antioxidants. Degradation products from gamma to e-beam sterilization processes to residual solvents from manufacturing may also be present.

Toxikon uses a combination of commercially-available reference database as well as a proprietary database, built over the last several decades, based on thousands of studies conducted.

Note: Toxikon is not performing pharmaceutical-only extractable and leachable studies in certain European and other countries until November 2020. Please contact our client relations team for more information.

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